Joint distraction device and system

Abstract

The invention relates to a joint distraction device and system. The joint distraction device comprises a rotating shaft assembly, an upper arm, a lower arm and a one-way locking mechanism. The upper arm and the lower arm are rotatably connected to the rotating shaft assembly and can conduct opening rotation and closing rotation around the rotating shaft assembly. The distraction rotation causes the upper front end of the upper arm and the lower front end of the lower arm to be away from each other, and the closure rotation causes the upper front end and the lower front end to be close to each other. The one-way locking mechanism has a one-way locking state and a free state. When in the one-way locking state, the one-way locking mechanism allows the upper arm and the lower arm to perform opening rotation and prevents the upper arm and the lower arm from performing closing rotation. When in the free state, the one-way locking mechanism allows the upper arm and the lower arm to perform opening rotation and closing rotation. The joint distraction device can be maintained in the distraction state through the one-way locking mechanism, the consistency and accuracy of obtained force data can be improved, and therefore the relation between a knee joint gap and soft tissue tension can be evaluated more accurately.

Description

Technical Field

[0001] The invention relates to the field of medical instruments, and in particular to an osteotomy auxiliary system used in knee replacement surgery. Background Art

[0002] Total knee arthroplasty (TKA) is the most effective treatment for end-stage knee osteoarthritis. Based on the difficulty, risk, cost and long-term efficacy of TKA surgery, the benefit-risk ratio of this treatment method is very high. However, the overall satisfaction of patients with the surgery is still only about 80%, and only about 60% of them feel that their knee joints are normal. The incidence of residual symptoms and dysfunction is about 33~54%, which leads to a high rate of TKA revision. Patients' dissatisfaction is mainly concentrated in postoperative pain, joint instability, and limited joint movement, all of which are related to the imbalance of soft tissues around the knee joint.

[0003] The normal knee joint is surrounded by a posterolateral complex composed of the tibial collateral ligament, the fibular collateral ligament, the anterior cruciate ligament, etc., and a posteromedial angle composed of the posteromedial joint capsule, the posterior oblique ligament, the oblique popliteal ligament, etc. These soft tissues of the knee joint jointly limit the valgus and rotation of the knee joint and provide stability for the knee joint. However, in TKA surgery, the soft tissues around the knee joint need to be removed in order to install the prosthesis. For example, the CR knee prosthesis requires the removal of the anterior cruciate ligament, and the PS knee prosthesis requires the removal of both the anterior cruciate ligament and the posterior cruciate ligament. Therefore, the knee joint after TKA surgery, such as the knee joint with the CR knee prosthesis installed, can only limit the valgus and rotation of the knee joint by providing coronal stability through the tibial and fibular collateral ligaments, and limit the anterior displacement of the tibia by providing sagittal stability through the posteromedial angle, the posterolateral complex, and the posterior cruciate ligament. After implanting an artificial joint prosthesis, overstretched knee soft tissue may cause joint pain, stiffness and reduced range of motion, while overly relaxed knee soft tissue may lead to joint instability and increase the number of collisions between prosthetic components, thereby increasing the risk of revision. Although there are many studies and technologies on soft tissue tension balance, on the one hand, the quantitative value of soft tissue tension is difficult to obtain accurately, and it depends more on the operator's sensory experience, and on the other hand, there are many differences between individual patients. Therefore, the current soft tissue tension balance method has not been widely recognized by the industry.

[0004] Currently, there are several methods on the market for obtaining soft tissue tension values.

[0005] 1. Method of adjusting the gap between knee joints with shims. The specific operation of this method is as follows: the user changes the joint gap by adding or reducing shims, and then evaluates whether the patient's soft tissue is balanced by touching the tension and tightness of the patient's soft tissue ligaments. However, this method has the following disadvantages: (1) It requires multiple pick-ups and drops to select a suitable gap assessment block for measurement, which is cumbersome to operate; (2) The processing error of each combined gap assessment block will cause a large overall thickness error after combination, resulting in a large gap measurement error, which can easily cause the thickness of the selected knee prosthesis to be inappropriate; (3) There is no quantitative data, and it is entirely based on experience, which makes it difficult to improve accuracy. It often relies on soft tissue release to balance the tension of the knee soft tissue, increasing the possibility of permanent soft tissue damage.

[0006] 2. The method of measuring the pressure changes in the medial and lateral compartments of the knee joint by means of a pressure sensor. The principle is to use a smart gasket equipped with a pressure sensor and having the same thickness and size as the standard trial gasket implant. The smart gasket can detect and record the pressure of the medial and lateral compartments of the knee joint during the trial and after the final implant placement. The surgeon compares these quantified values ​​with the standard values ​​of the balanced knee joint to decide whether additional treatment (such as re-osteotomy, soft tissue release, etc.) is needed to achieve soft tissue tension balance. However, this method also has many disadvantages, such as: (1) Due to individual differences, there is a possibility that consistent and continuous contact with a specific joint surface cannot be made, and studies have found that when pressure occurs outside the sensing area of ​​the sensor, the measurement error of the pressure sensor will increase, resulting in inaccurate measurement of the tibiofemoral contact force and contact position; (2) The tibial resection must be completed before the trial measurement action can be performed using this method.

[0007] In summary, the existing soft tissue tension assessment methods need to be improved to enhance patients' satisfaction with TKA surgery. Summary of the invention

[0008] The technical solution proposed in the present invention aims to solve the problem caused by the imbalance of soft tissue around the knee joint after surgery in the prior art.

[0009] In one aspect of the present invention, a joint distraction device is provided, which includes: a pivot assembly; an upper arm and a lower arm, which are rotatably connected to the pivot assembly and can perform distraction rotation and closing rotation around the pivot assembly, the distraction rotation causes the upper front end of the upper arm and the lower front end of the lower arm to move away from each other, and the closing rotation causes the upper front end of the upper arm and the lower front end of the lower arm to move closer to each other; and a one-way locking mechanism, which has a one-way locking state and a free state, wherein, when in the one-way locking state, the one-way locking mechanism allows the upper arm and the lower arm to perform distraction rotation and prevents the upper arm and the lower arm from performing closing rotation; when in the free state, the one-way locking mechanism allows the upper arm and the lower arm to perform distraction rotation and closing rotation.

[0010] In at least one embodiment of one aspect of the present invention, the joint distraction device further comprises one or more force sensors, each of which is located at the upper arm or the lower arm for measuring the force exerted on the upper arm or the lower arm.

[0011] In at least one embodiment of one aspect of the present invention, the upper arm has an upper front portion and a lower rear portion divided by the rotating shaft assembly, the lower arm has an upper front portion and a lower rear portion divided by the rotating shaft assembly, the upper front portion of the upper arm has the upper front end, the lower front portion of the lower arm has the lower front end, the upper front end and the lower front end are configured to be suitable for insertion into a patient's joint, the upper rear portion of the upper arm and the lower rear portion of the lower arm respectively have an upper operating portion and a lower operating portion for applying force thereon to cause the upper arm and the lower arm to open and rotate, and each of the one or more force sensors is located at the upper rear portion of the upper arm or the lower rear portion of the lower arm.

[0012] In at least one embodiment of one aspect of the present invention, the upper rear portion of the upper arm has a cantilever beam, the cantilever beam is configured to have a force-sensitive area, and at least one of the one or more force sensors is located within the force-sensitive area of ​​the cantilever beam of the upper arm.

[0013] In at least one embodiment of one aspect of the present invention, the upper arm has a housing including a first shell portion, which is flexible and bendable and completely surrounds the force sensitive area for positioning at least one force sensor.

[0014] In at least one embodiment of one aspect of the present invention, the upper arm has a reinforcing metal member, and the reinforcing metal member is used to be installed in the housing.

[0015] In at least one embodiment of one aspect of the present invention, the one-way locking mechanism includes a locking piece and a locking mating piece, and when the one-way locking mechanism is in the one-way locking state, the locking piece and the locking mating piece are in a first predetermined position relative to each other; and when the one-way locking mechanism is in the free state, the locking piece and the locking mating piece are in a second predetermined position relative to each other.

[0016] In at least one embodiment of one aspect of the present invention, the locking member has a first tooth surface, the locking mating member has a second tooth surface, the first predetermined position includes the first tooth surface meshing with the second tooth surface, the second predetermined position includes the first tooth surface being separated from the second tooth surface, and the first tooth surface and the second tooth surface are configured such that: when the first tooth surface is meshing with the second tooth surface, the locking member and the locking mating member can only move in a single direction respectively, so that the upper arm and the lower arm can only rotate relative to each other.

[0017] In at least one embodiment of one aspect of the present invention, the lower rear portion of the lower arm has an opening, the first tooth surface of the locking member is arranged in the opening, one end of the locking fitting is connected to the upper arm, and the other end is used to pass through the opening of the lower arm, and the one-way locking mechanism also includes: an elastic member, which is located at the connection between the locking fitting and the upper arm, and is used to push the second tooth surface of the locking fitting toward the first tooth surface of the locking member; and a switch, which is located on the lower arm and is used to be operated to push the second tooth surface of the locking fitting away from the first tooth surface of the locking member.

[0018] In at least one embodiment of one aspect of the present invention, the shaft assembly includes: a shaft, which is connected to the upper arm and has a diameter-changing region; and a sleeve, which is connected to the lower arm and is used to sleeve the shaft, the locking fitting includes the diameter-changing region of the shaft, the locking member includes an extrusion member, the extrusion member is arranged in the cavity of the lower arm for abutting the diameter-changing region of the shaft, the first predetermined position includes the extrusion member abutting the diameter-changing region of the shaft, and the second predetermined position includes the extrusion member being separated from the diameter-changing region of the shaft.

[0019] In at least one embodiment of one aspect of the present invention, the one-way locking mechanism also includes: a push rod, which is disposed in the cavity of the lower arm; and a button, a portion of which is disposed in the cavity of the lower arm, and the button is used to be operated to push the push rod toward the extrusion member, thereby causing the extrusion member to abut the variable diameter area of ​​the rotating shaft.

[0020] In at least one embodiment of one aspect of the present invention, the lower rear portion of the lower arm has an opening, and the locking fitting includes a threaded rod, a first end of the threaded rod is connected to the upper arm, and a second end is used to pass through the opening of the lower arm, the threaded rod includes a locking section and a non-locking section, the outer surface of the locking section has a thread, the locking section of the threaded rod is closer to the first end than the non-locking section, the locking member includes a nut for sleeved on the threaded rod from the second end of the threaded rod, the first predetermined position includes the nut being threadedly connected to the threaded rod in the locking section of the threaded rod, and the second predetermined position includes the nut being located in the non-locking section of the threaded rod or the nut being separated from the threaded rod.

[0021] In at least one embodiment of one aspect of the present invention, the joint distraction device further includes a position sensor, wherein the position sensor is configured to measure position data, and the position data is used to determine a distraction distance of the joint distraction device.

[0022] In at least one embodiment of one aspect of the present invention, the position sensor includes an angle encoder, which is located at the shaft assembly and is configured to measure a rotation angle.

[0023] In another aspect of the present invention, a joint distraction system is provided, which includes: a joint distraction device as described in the preceding paragraphs; a processing module, which is communicatively coupled to the joint distraction device and is configured to: receive one or more force data from a force sensor and one or more position data from a position sensor from the joint distraction device; determine one or more distraction pressures based on the one or more force data; and determine one or more distraction distances based on the one or more position data; and a display module, which is communicatively coupled to the processing module and is configured to display the determined one or more distraction pressures and one or more distraction distances.

[0024] In at least one embodiment of another aspect of the present invention, the display module is further configured to: display each distraction data of the one or more distraction distances in association with a corresponding distraction pressure of the one or more distraction pressures.

[0025] In at least one embodiment of another aspect of the present invention, the one or more position data are acquired for each of the one or more measurement positions, and the one or more force data are acquired for each of the one or more measurement positions.

[0026] In at least one embodiment of another aspect of the present invention, the processing module is further configured to: perform osteotomy amount analysis based on the distraction pressure and its corresponding distraction distance determined for each of one or more measurement positions to determine the osteotomy amount, and the display module is configured to display the determined osteotomy amount.

[0027] In at least one embodiment of another aspect of the present invention, the bone resection amount analysis includes: determining multiple distraction pressures and their corresponding distraction distances within a predetermined distraction pressure range based on the distraction pressures and their corresponding distraction distances obtained for each measuring position; drawing a curve graph of the distraction pressure change relative to the distraction distance based on the multiple distraction pressures and their corresponding distraction distances within the predetermined distraction pressure range; determining a target distraction distance based on the slope of the drawn curve graph, the target distraction distance being the distraction distance corresponding to the characteristic point in the curve graph; and determining the bone resection amount based on the target distraction distance.

[0028] The technical solution proposed by the present invention may have at least one of the following advantages:

[0029] (1) By dynamically evaluating the relationship between the knee joint gap and soft tissue tension before osteotomy, it can help improve the precision and accuracy of knee replacement surgery and promote the standardization of research on knee soft tissue tension balance, providing new ideas and methods for the treatment of knee diseases;

[0030] (2) In the process of using the joint distractor to distract the joint gap to obtain force data related to soft tissue tension, the one-way locking mechanism can maintain the joint distractor in the distracted state, which can improve the consistency and accuracy of the force data obtained, thereby more accurately evaluating the relationship between the knee joint gap and soft tissue tension. BRIEF DESCRIPTION OF THE DRAWINGS

[0031] In order to further illustrate the above and other advantages and features of various embodiments of the present invention, a more specific description of various embodiments of the present invention will be presented with reference to the accompanying drawings. It should be understood that these drawings only depict typical embodiments of the present invention and are therefore not to be considered as limiting the scope of protection claimed by the present invention.

[0032] Figure 1 A schematic diagram of a joint distraction system according to an embodiment of the present invention is shown.

[0033] Figure 2 A schematic diagram showing a joint distraction device according to some embodiments of the present invention installed in the lateral gap of the left knee joint.

[0034] Figure 3A schematic diagram of a joint distraction device installed in the lateral gap of a left knee joint in a distracted state according to some embodiments of the present invention is shown.

[0035] Figure 4 A schematic structural diagram of a joint distraction device in a closed state according to some embodiments of the present invention is shown at a certain viewing angle.

[0036] Figure 5 A schematic structural diagram of a joint distraction device in a closed state according to some embodiments of the present invention is shown from another perspective.

[0037] Figure 6 A schematic structural diagram of a joint distraction device in a distraction state according to some embodiments of the present invention is shown at a certain viewing angle.

[0038] Figure 7 A schematic structural diagram of a joint distraction device in a distraction state according to some embodiments of the present invention is shown from another perspective.

[0039] Figure 8 A schematic structural diagram showing a one-way locking mechanism of a joint distraction device according to another embodiment of the present invention in a one-way locking state is shown.

[0040] Fig. 9 A partial enlarged structural schematic diagram of a one-way locking mechanism of a joint distraction device according to other embodiments of the present invention is shown in a one-way locking state.

[0041] Fig.10 A schematic structural diagram showing a one-way locking mechanism of a joint distraction device in a free state according to other embodiments of the present invention is shown.

[0042] Fig.11 A schematic structural diagram showing a one-way locking mechanism of a joint distraction device in a free state according to other embodiments of the present invention is shown.

[0043] Fig.12 A partial exploded schematic diagram of an upper arm of a joint spreading shaft according to an embodiment of the present invention is shown.

[0044] Fig.13 A method for performing bone resection amount analysis according to an embodiment of the present invention is shown.

[0045] Fig.14 A graph showing the change in distraction pressure relative to distraction distance according to some embodiments of the present disclosure is shown. DETAILED DESCRIPTION

[0046] The present invention is further described below in conjunction with specific embodiments and drawings. More details are elaborated in the following description to facilitate a full understanding of the present invention. However, the present invention can obviously be implemented in a variety of other ways different from the description herein. Those skilled in the art can make similar generalizations and deductions based on actual application situations without violating the connotation of the present invention. Therefore, the protection scope of the present invention should not be limited by the content of this specific embodiment.

[0047] The present application uses specific words to describe the embodiments of the present application. For example, "one embodiment", "other embodiments", and / or "some embodiments" refer to a certain feature, structure or characteristic related to at least one embodiment of the present application. Therefore, it should be emphasized and noted that "one embodiment" or "other embodiments" or "some embodiments" mentioned twice or multiple times in different positions in this specification do not necessarily refer to the same embodiment. In addition, some features, structures or characteristics in one or more embodiments of the present application can be appropriately combined.

[0048] It should be noted that in order to simplify the description of the disclosure of this application and thus help understand one or more embodiments, the disclosure of the embodiments of this application sometimes combines multiple features into one embodiment, drawing or description thereof. However, this disclosure method does not mean that the features required by the object of this application are more than the features mentioned in the claims.

[0049] In the description of the present disclosure, it should be noted that the terms "clockwise", "counterclockwise", "center", "up", "down", "left", "right", "vertical", "horizontal", "inside", "outside" and the like indicate positions or positional relationships based on the positions or positional relationships shown in the drawings, and are only for the convenience of describing the present disclosure and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific position, be constructed and operated in a specific position, and therefore cannot be understood as a limitation of the present disclosure. In the present disclosure, the end close to the operator (e.g., doctor) is defined as the rear end, the rear part, and the end close to the surgical patient is defined as the front end, the front part.

[0050] Reference Figure 1 , Figure 1 A schematic diagram of a joint distraction system 100 according to an embodiment of the present invention is shown.

[0051] like Figure 1As shown, a joint distraction system 100 (hereinafter referred to as system 100) may include a joint distraction device 10, a processing module 20 and a display module 30. The joint distraction device 10 can distract a patient's joint, such as a knee joint. The joint distraction device 10 may include one or more force sensors 101. In the process of distracting a patient's joint using the joint distraction device 10, the force sensor 101 on the joint distraction device 10 can measure force data, and the measured force data can reflect the tension of the soft tissue around the patient's joint. In some embodiments, the force sensor 101 may include a resistance strain gauge. The joint distraction device 10 may also include one or more position sensors 103. In the process of distracting a patient's joint using the joint distraction device 10, the position sensor 103 on the joint distraction device 10 can measure position data, and the measured position data can be used to determine the distraction distance of the joint distraction device 10 (i.e., the distance the joint is distracted). In some embodiments, the position sensor 103 may include an angle encoder, and the angle encoder may be located at the rotating shaft assembly 130 ( Figure 1 Not shown, see Figure 4 ) and is configured to measure a rotation angle, and the measured rotation angle can be used to determine the distraction distance of the joint distraction device 10 (i.e., the distance the joint is distracted). In other embodiments, the position sensor 103 may include a Hall sensor, and the distraction distance of the joint distraction device 10 (i.e., the distance the joint is distracted) can be determined by using data measured by the Hall sensor.

[0052] See also Figure 1 , the processing module 20 may be communicatively coupled to the joint distraction device 10. The processing module 20 may be configured to receive force data and position data from the joint distraction device 10. The display module 30 may be communicatively coupled to the processing module 20 and / or the joint distraction device 10 and may be configured to receive information from the processing module 20 and / or the joint distraction device 10 and display the received information.

[0053] In operation, joint distraction device 10 may be installed at a joint (eg, a knee joint) of a patient. Figure 2 A schematic diagram showing a joint distraction device 10 according to some embodiments of the present invention installed in the outer gap of the left knee joint 40. Figure 2As shown, the joint distraction device 10 may include an upper arm 110 and a lower arm 120, and the upper front end 111 of the upper arm 110 and the lower front end 121 of the lower arm 120 are in a closed state and inserted into the lateral gap of the patient's left knee joint 40. When the joint distraction device 10 is inserted into the lateral gap of the patient's left knee joint 40, the upper front end 111 of the upper arm 110 may contact the femoral condyle (not shown in the figure), and the lower front end 121 of the lower arm 120 may contact the tibial plateau (not shown in the figure) of the knee joint 40. The upper arm 110 and the lower arm 120 may be distracted and rotated relative to each other under the action of an external force, so that the upper front end 111 of the upper arm 110 and the lower front end 121 of the lower arm 120 are away from each other. Figure 3 FIG. 1 is a schematic diagram showing a joint distraction device 10 installed in the outer gap of the left knee joint 40 in a distraction state according to some embodiments of the present invention. Figure 3As shown, the upper front end 111 of the upper arm 110 and the lower front end 121 of the lower arm 120 of the joint distraction device 10 are in a distracted state. In this distracted state, the upper front end 111 of the upper arm 110 is separated from the lower front end 121 of the lower arm 120 by a certain distance. At this time, the tibial plateau and the femoral condyle of the knee joint 40 are also distracted by the upper arm 110 and the lower arm 120 of the joint distraction device 10 by a certain distance. Under the tension of the surrounding soft tissue (not shown in the figure), the tibial plateau and the femoral condyle will generate a squeezing force on the upper front end 111 of the upper arm 110 and the lower front end 121 of the lower arm 120 of the joint distraction device 10. The force sensor 101 located at the upper arm 110 or the lower arm 120 can measure the force applied to the upper arm 110 or the lower arm 120. When the upper front end 111 of the upper arm 110 and the lower front end 121 of the lower arm 120 are at different distraction distances (i.e., the upper front end 111 of the upper arm 110 and the lower front end 121 of the lower arm 120 are separated by different distances), the distances at which the knee joint 40 is distracted by the upper arm 110 and the lower arm 120 of the joint distraction device 10 will be different, which will result in different squeezing forces on the upper arm 110 and the lower arm 120 generated by the tibial plateau and the femoral condyle of the knee joint 40 under the tension of the surrounding soft tissue. Generally speaking, the squeezing force may increase with the increase of the distraction distance. By using the position data measured by the position sensor 103 to determine the distracted height of the tibial plateau and the femoral condyle of the knee joint 40, and using the force data measured by the force sensor 101 to determine the soft tissue tension, the soft tissue tension at different distraction distances can be obtained, so that the relationship between the joint gap and the soft tissue tension can be evaluated. This can help doctors determine the appropriate amount of osteotomy during knee replacement surgery, avoid relying on soft tissue release to balance the tension of the soft tissue of the knee joint, and reduce the possibility of permanent damage to the soft tissue around the knee joint after surgery, thereby improving the patient's postoperative comfort and increasing the patient's satisfaction with the surgery. In addition, those skilled in the art can use the joint distraction system 100 disclosed in the present invention to dynamically evaluate the relationship between the knee joint gap and the soft tissue tension, which can promote the standardization process of the research on the tension balance of the soft tissue of the knee joint and provide new ideas and methods for the treatment of knee joint diseases.

[0054] The following will be combined Figure 4-Figure 7 The construction of joint distraction device 10 will be described in detail. Figure 4 A schematic structural diagram of a joint distraction device 10 in a closed state according to some embodiments of the present invention is shown at a certain viewing angle. Figure 5 A schematic structural diagram of the joint distraction device 10 in a closed state according to some embodiments of the present invention is shown from another perspective. Figure 6 A schematic structural diagram of a joint distraction device 10 in a distraction state according to some embodiments of the present invention is shown at a certain viewing angle. Figure 7 A schematic structural diagram of a joint distraction device 10 in a distraction state according to some embodiments of the present invention is shown from another perspective.

[0055] See also Figure 4-7 , the joint distraction device 10 may include an upper arm 110, a lower arm 120, and a rotating shaft assembly 130. The upper arm 110 and the lower arm 120 are rotatably connected at the rotating shaft assembly 130. With the rotating shaft assembly 130 as a boundary, the upper arm 110 can be divided into an upper front portion 112 and an upper rear portion 114, and the lower arm 120 can be divided into a lower front portion 122 and a lower rear portion 124. The upper front portion 112 of the upper arm 110 can have an upper front end 111, and the lower front portion 122 of the lower arm 120 can have a lower front end 121. The upper arm 110 and the lower arm 120 can perform distraction rotation and closing rotation around the rotating shaft assembly 130. During the distraction rotation process, the upper front end 111 of the upper arm 110 and the lower front end 121 of the lower arm 120 can be separated from each other. During the closing rotation process, the upper front end 111 of the upper arm 110 and the lower front end 121 of the lower arm 120 can be close to each other. When joint distraction device 10 is in a closed state, upper front end 111 of upper arm 110 and lower front end 121 of lower arm 120 may be relatively close to each other. Figure 4 and Figure 5 As shown, when the joint distraction device 10 is in the closed state, the upper front end 111 and the lower front end 121 may contact each other, that is, the distance between the upper front end 111 and the lower front end 121 is zero. In other embodiments, when the joint distraction device 10 is in the closed state, the upper front end 111 and the lower front end 121 may be slightly spaced apart, that is, separated by a non-zero distance. When the joint distraction device 10 is in the distracted state, the upper front end 111 of the upper arm 110 and the lower front end 121 of the lower arm 120 may be spaced apart from each other and separated by a larger distance than in the closed state, such as Figure 6 and Figure 7 shown.

[0056] In some embodiments, the upper front end 111 and the lower front end 121 may be configured as tooth-like structures, such as Figure 7 As shown. In other embodiments, the upper front end 111 and / or the lower front end 121 may be configured as other structures, for example, a double-pointed structure, a single-pointed structure, etc. The upper front end 111 may be configured to be integrally formed with other parts of the upper arm 110 or to be detachable relative to other parts of the upper arm 110. Similarly, the lower front end 121 may be configured to be integrally formed with other parts of the lower arm 120 or to be detachable relative to other parts of the lower arm 120. The detachable upper front end 111 and / or lower front end 121 may allow the upper front end 111 and / or lower front end 121 to be customized in a suitable shape for the patient. In addition, the detachable upper front end 111 and / or lower front end 121 may also allow the joint distraction device 10 to be reused for different patients, and only the upper front end 111 and / or lower front end 121 need to be replaced. This can not only improve the safety of the operation, but also reduce the cost of the operation.

[0057] See also Figure 4-Figure 7 The upper rear portion 114 of the upper arm 110 may have an upper operating portion 113, and the lower rear portion 124 of the lower arm 120 may have a lower operating portion 123. The upper operating portion 113 and the lower operating portion 123 may be used by an operator (e.g., a doctor) to apply force thereon, so that the upper arm 110 and the lower arm 120 are spread and rotated around the rotating shaft assembly 130, thereby increasing the spread distance between the upper front end 111 and the lower front end 121.

[0058] In some embodiments, the force sensor 101 may be positioned at the upper rear portion 114 of the upper arm 110 or the lower rear portion 124 of the lower arm 120. When the force sensor 101 is positioned at the upper rear portion 114 of the upper arm 110 or the lower rear portion 124 of the lower arm 120, if the operator's force application point on the upper arm 110 or the lower arm 120 changes, then even if the operator applies the same force to the upper arm 110 or the lower arm 120, the force data measured by the force sensor 101 will also change. In order to solve this problem, the present invention proposes to set a one-way locking mechanism 140 (or one-way locking mechanism 150 or 160) in the joint distraction device 10 (or joint distraction device 50 or 60). The one-way locking mechanism 140 (or one-way locking mechanism 150 or 160) will be described in detail below.

[0059] In other embodiments, the force sensor 101 may be positioned at the upper front portion 112 of the upper arm 110 or the lower front portion 122 of the lower arm. For example, the force sensor 101 may be positioned at a portion other than the upper front end 111 of the upper front portion 112 of the upper arm 110, or the force sensor 101 may be positioned at a portion other than the lower front end 121 of the lower front portion 122 of the lower arm 110. The force data measured by the force sensor 101 positioned at the upper front portion 112 or the lower front portion 122 will not be affected by the force application point of the operator.

[0060] See also Figure 4-Figure 7 The joint distraction device 10 may further include a one-way locking mechanism 140. The one-way locking mechanism 140 may be used to prevent the upper arm 110 and the lower arm 120 from rotating around the rotating shaft assembly 130, thereby maintaining the joint distraction device 10 in a distracted state. By maintaining the joint distraction device 10 in a distracted state by using the one-way locking mechanism 140, rather than by the operator applying force to maintain the joint distraction device 10 in a distracted state, the influence of the change of the force application point of the operator on the consistency of the force data measured by the force sensor 101 (for example, the force sensor 101 located at the lower rear portion 114 of the upper arm 110 or the lower rear portion 124 of the lower arm 120) may be eliminated.

[0061] The one-way locking mechanism 140 may have a one-way locking state and a free state. In the one-way locking state, the one-way locking mechanism 140 may only allow the upper arm 110 and the lower arm 120 to rotate openly around the rotating shaft assembly 130 and prevent the upper arm 110 and the lower arm 120 from rotating closedly around the rotating shaft assembly 130. In the free state, the one-way locking mechanism 140 may allow the upper arm 110 and the lower arm 120 to rotate openly and closedly around the rotating shaft assembly 130.

[0062] See also Figure 4-Figure 7 , the one-way locking mechanism 140 may include a locking member 141 and a locking fitting member 143. When the one-way locking mechanism 140 is in the one-way locking state, the locking member 141 and the locking fitting member 143 may be in a first predetermined position relative to each other, for example, the locking member 141 is engaged with the locking fitting member 143. When the one-way locking mechanism 140 is in the free state, the locking member 141 and the locking fitting member 143 may be in a second predetermined position relative to each other, for example, the locking member 141 is separated from the locking fitting member 143. Figure 5 In the illustrated embodiment, the locking member 141 may have a first tooth surface 1411, which may be located in the opening 125 of the lower rear portion 124 of the lower arm 120. The locking fitting 143 may have a second tooth surface 1431, and one end of the locking fitting 143 may be connected to the upper rear portion 114 of the upper arm 110, and the other end may pass through the opening 125 of the lower rear portion 124 of the lower arm 120.

[0063] See also Figure 5 The one-way locking mechanism 140 may further include an elastic member 145, such as a torsion spring. The elastic member 145 may be located at the connection between the locking fitting 143 and the upper arm 110, and is used to push the second tooth surface 1431 of the locking fitting 143 toward the first tooth surface 1411 of the locking member 141, so as to force the first tooth surface 1411 to engage with the second tooth surface 1431. When the first tooth surface 1411 is engaged with the second tooth surface 1431, the locking member 141 can only move in the first direction L1 relative to the locking fitting 143, and the locking fitting 143 can only move in the second direction L2 relative to the locking member 141. At this time, the upper arm 110 and the lower arm 120 can only be spread and rotated around the rotating shaft assembly 130. That is, when the first tooth surface 1411 is engaged with the second tooth surface 1431, the one-way locking mechanism 140 is in a one-way locking state.

[0064] See also Figure 5 The one-way locking mechanism 140 may further include a switch 147. The switch 147 may be located near the opening 125 of the lower rear portion 124 of the lower arm 120. The opening 147 may be operated to push the second tooth surface 1431 of the locking fitting 143 away from the first tooth surface 1411 of the locking member 141. For example, the switch 147 may be toggled to be in a state such as Figure 5In the first state, one end 1471 of the switch 147 abuts against the locking member 143 to push the second tooth surface 1431 of the locking member 143 away from the first tooth surface 1411 of the locking member 141, thereby releasing the engagement between the first tooth surface 1411 and the second tooth surface 1431. When the engagement between the first tooth surface 1411 and the second tooth surface 1431 is released, the one-way locking mechanism 140 can be in a free state. The switch 147 can also be placed as shown in FIG. Figure 6 In the second state, one end 1471 of the switch 147 no longer abuts against the locking fitting 143. At this time, the second tooth surface 1431 of the locking fitting 143 can contact and engage with the first tooth surface 1411 of the locking member 141 under the action of the elastic member 145, so that the one-way locking mechanism 140 is in the one-way locking state.

[0065] In addition to the above references Figure 4-Figure 7 In addition to the joint distraction device 10 described above, the joint distraction system 100 may also include other joint distraction devices, such as, Figure 8-Figure 10 The joint distraction device 50 shown, Fig.11 The joint distraction device 60 shown. Most of the components of the joint distraction devices 10, 50 and 60 (eg, upper arm 110, lower arm 120, shaft assembly 130) may be constructed to be substantially the same, and the difference between them may be that the one-way locking mechanism is different.

[0066] Figure 8 A schematic structural diagram of a one-way locking mechanism 150 of a joint distraction device 50 according to another embodiment of the present invention is shown in a one-way locking state. Fig. 9 A partial enlarged structural schematic diagram of a one-way locking mechanism 150 of a joint distraction device 50 according to another embodiment of the present invention in a one-way locking state is shown. Fig.10 It shows a schematic structural diagram of a one-way locking mechanism 150 of a joint distraction device 50 in a free state according to another embodiment of the present invention.

[0067] See also Figure 8 , the joint distraction device 50 may include a shaft assembly 130. In some embodiments, the above combination Figure 4-Figure 7 The described rotation shaft assembly 130 of the joint distraction device 10 and / or the following combination Fig.11 The described joint distraction device 60 may be provided with a shaft assembly 130 that is substantially similar to the following: Figure 8 The shaft assembly 130 of the joint distraction device 50 is described. Figure 8As shown, the shaft assembly 130 may include a shaft 131 and a sleeve 133. The shaft 131 may be connected to the upper arm 110, the sleeve 133 may be connected to the lower arm 120, and the sleeve 133 may be sleeved on the shaft 131. When the upper arm 110 and the lower arm 120 rotate around the shaft assembly 130, the shaft 131 may rotate counterclockwise in the sleeve 133. When the upper arm 110 and the lower arm 120 rotate around the shaft assembly 130, the shaft 131 may rotate clockwise in the sleeve 133.

[0068] See also Figure 8 The joint distraction device 50 may further include an upper arm 110 and a lower arm 120. The upper arm 110 and the lower arm 120 of the joint distraction shaft 50 may be respectively similar to the above combination Figure 4-Figure 7 The upper arm 110 and the lower arm 120 of the joint distraction device 50 are described.

[0069] See also Figure 8-Figure 10 The joint distraction device 50 may further include a one-way locking mechanism 150. Fig. 9 As shown, the one-way locking mechanism 150 may include a locking member 151 and a locking fitting member 153. When the one-way locking mechanism 150 is in the one-way locking state, the locking member 151 and the locking fitting member 153 may be in a first predetermined position relative to each other, for example, the locking member 151 may abut against the locking fitting member 153. Fig. 9 In the illustrated embodiment, the locking member 151 may include an extrusion member 152, which may be disposed in a cavity of the lower arm 120. The cavity may be in communication with the sleeve 133. The locking fitting 153 may include a reduced diameter region 1311 of the rotating shaft 131. The rotating shaft 131 may have the following diameter characteristics in the reduced diameter region 1311: the diameter of the rotating shaft 131 in the reduced diameter region 1311 is smaller than the diameter of other portions of the rotating shaft 131, and the diameter of the rotating shaft 131 in the reduced diameter region 1311 gradually increases in a clockwise direction. When a portion of the extrusion piece 152 penetrates into the shaft sleeve 133 and the extrusion piece 152 abuts against the diameter-changing region 1311 of the rotating shaft 131, due to the above-mentioned diameter characteristics of the rotating shaft 131 in the diameter-changing region 1311 (i.e., the diameter of the rotating shaft 131 in the diameter-changing region 1311 is smaller than the diameter of other parts of the rotating shaft 131 and gradually increases in the clockwise direction), the rotating shaft 131 may not be able to rotate counterclockwise in the shaft sleeve 133, but can only rotate clockwise in the shaft sleeve 133. This may cause the upper arm 110 and the lower arm 120 to be able to rotate openly around the rotating shaft assembly 130, but not to be able to rotate closedly around the rotating shaft assembly 130.

[0070] Continue to see Fig. 9, the one-way locking mechanism 150 may further include a push rod 155 and a button 157. The abutment of the extrusion member 152 against the diameter-changing region 1311 of the rotating shaft 131 may be accomplished through the cooperation among the extrusion member 152, the push rod 155 and the button 157. In some embodiments, the button 157 may be pressed by an operator to push the push rod 155 toward the extrusion member 152, thereby causing the extrusion member 152 to abut against the diameter-changing region 1311 of the rotating shaft 131. When the operator releases the pressing force on the button 157, the push rod 155 moves away from the extrusion member 152, thereby causing the extrusion member 152 to separate from the diameter-changing region 1311 of the rotating shaft 131.

[0071] like Fig. 9 As shown, the extrusion member 152 may have an extrusion head 1521, an extrusion positioning portion 1522, and an extrusion tail 1523. The extrusion positioning portion 1522 may be rotatably fixed to the inner wall of the cavity of the lower arm 120. The extrusion head 1521 and the extrusion tail 1523 may be connected to the extrusion positioning portion 1522. The push rod 155 may be disposed in the cavity of the lower arm 120. The push rod 155 may have a first push rod portion 1551, a push rod recess 1553, and a second push rod portion 1555 along its extension direction. One end of the first push rod portion 1551 close to the push rod recess 1553 may have a push rod inclined surface 1552, and the other end of the first push rod portion 1551 away from the push rod recess 1553 may be connected to the first spring 158. A portion of the button 157 may be disposed in the cavity of the lower arm 120. The button 157 may include a first button portion 1571, a button recess 1573, and a second button portion 1575 along its extension direction. One end of the first button portion 1571 away from the button recess 1573 may be connected to the second spring 159. One end of the second button portion 1575 close to the button recess 1573 may include a button slope 1572, and the other end of the second button portion 1575 away from the button recess 1573 may include a button operating portion 1574.

[0072] See also Fig. 9 When the one-way locking mechanism 150 is in the one-way locking state, the extrusion head 1521 can abut against the variable diameter area 1311 of the rotating shaft 131, the extrusion tail 1523 can be clamped between the second push rod portion 1555 and the inner wall of the cavity of the lower arm 120, and the first push rod portion 1551 can be at least partially located in the key recess 1573.

[0073] When the operator presses the key operating portion 1574 upward, the key inclined surface 1572 and the push rod inclined surface 1552 can slide along each other, so that the push rod 155 as a whole moves in a direction away from the extrusion member 152 (in the direction of Fig. 9At this time, the extrusion tail 1523 may fall back under the action of gravity, thereby driving the extrusion positioning portion 1522 to rotate clockwise. The extrusion positioning portion 1522 rotating clockwise may further drive the extrusion head 1521 to move away from the diameter-changing region 1311 of the rotating shaft 131. When the extrusion head 1521 is separated from the diameter-changing region 1311 of the rotating shaft 131, the one-way locking mechanism 150 may be in a free state, such as Fig.10 shown.

[0074] When the one-way locking mechanism 150 is in a free state, the extrusion head 1521 is separated from the diameter-changing region 1311 of the rotating shaft 131, the extrusion tail 1523 is located between the second push rod portion 1555 and the inner wall of the cavity of the lower arm 120, and the extrusion tail 1523 contacts the second push rod portion 1555 but does not contact the inner wall of the cavity of the lower arm 120, and the second button portion 1575 may be at least partially located in the push rod recess 1553. In some embodiments, compared with the one-way locking state, the first spring 158 and the second spring 159 of the one-way locking mechanism 150 in the free state are further compressed, so that when the operator releases the pressing force applied at the button operating portion 1574, the compressed second spring 159 can use its restoring force to make the button 157 move downward as a whole, and the compressed first spring 158 can use its restoring force to make the push rod 155 move toward the direction close to the extrusion member 152 as a whole (in the direction of the one-way locking state). Fig.10 In the embodiment of the present invention, the one-way locking mechanism 150 is moved in the left direction (in the left direction), thereby restoring the one-way locking mechanism 150 to the one-way locking state. In this way, the initial state of the one-way locking mechanism 150 can be set to the one-way locking state.

[0075] Fig.11 It shows a schematic structural diagram of a one-way locking mechanism 160 of a joint distraction device 60 in a free state according to another embodiment of the present invention.

[0076] See also Fig.11 The joint distraction device 60 may include an upper arm 110 and a lower arm 120. The upper arm 110 and the lower arm 120 of the joint distraction shaft 60 may be respectively similar to the above combination Figure 4-Figure 7 The upper arm 110 and the lower arm 120 of the joint distraction device 50 are described. The joint distraction device 60 may also include a shaft assembly 130. The shaft assembly 130 of the joint distraction device 60 may be substantially similar to the above combination. Figure 8 The shaft assembly 130 of the joint distraction device 50 is described.

[0077] See also Fig.11, the joint distraction device 60 may further include a one-way locking mechanism 160. The one-way locking mechanism 160 may include a nut 161 and a threaded rod 163. The first end 162 of the threaded rod 163 may be connected to the upper rear portion 114 of the upper arm 110, and the second end 164 may pass through the opening 125 of the lower rear portion 124 of the lower arm 120. The outer size of the nut 161 may be larger than the size of the opening 125 of the lower arm 120, so that the nut 161 cannot pass through the opening 125. In use, the nut 161 may be sleeved on the threaded rod 163 from the second end 164 of the threaded rod 163.

[0078] See also Fig.11 The threaded rod 163 may have a locking section 1631 and a non-locking section 1633. The outer surface of the locking section 1631 has threads to facilitate threaded connection with the nut 161. The outer surface of the non-locking section 1633 may have threads (such as Fig.11 ) or without threads (not shown). Fig.11 As shown, the locking section 1631 is closer to the first end 162 of the threaded rod 163 than the non-locking section 1633. In other words, the non-locking section 1633 is closer to the second end 164 of the threaded rod 163 than the locking section 1631.

[0079] When the operator uses the one-way locking mechanism 160, the nut 161 is screwed to be threadedly connected with the threaded rod 163 in the locking section 1631 and abuts against the lower arm 120, thereby preventing the upper arm 110 and the lower arm 120 from rotating around the rotating shaft assembly 130, and allowing the upper arm 110 and the lower arm 120 to rotate around the rotating shaft assembly 130. At this time, the one-way locking mechanism 160 can be in a one-way locking state.

[0080] When the nut 161 is placed in the non-locking section 1633 of the threaded rod 163 (e.g., Fig.11 As shown, when the nut 161 is threadedly connected to the threaded rod 163 in the non-locking section 1633, the joint distraction device 60 can be placed in a closed state. Since the final result of the closed rotation is to put the joint distraction device 60 in a closed state, it can be considered that: when the nut 161 is placed in the non-locking section 1633 of the threaded rod 163, the one-way locking mechanism 160 is in a free state, that is, the upper arm 110 and the lower arm 120 can perform a closed rotation and a distraction rotation around the rotating shaft assembly 130. In addition, the one-way locking mechanism 160 can also be placed in a free state by separating the nut 161 from the threaded rod 163.

[0081] See also Fig.12 , Fig.12 FIG. 1 is a partial exploded schematic diagram of the upper arm 110 of the joint spreading shaft 10, 50 or 60 according to an embodiment of the present invention. Fig.12As shown, the upper rear portion 114 of the upper arm 110 may have a housing 115 and a cantilever beam 116. The cantilever beam 116 may be located within the housing 115. The cantilever beam 116 may be configured to have a force sensitive region for at least one force sensor 101 to be fixed thereon (e.g., fixed by gluing). The force sensitive region may be configured to include holes, grooves, notches, fillets, or other irregular shapes in the design of the sensitive beam. By providing a force sensitive region on the cantilever beam 116, the force received by the upper arm 110 may be concentrated in the force sensitive region, thereby improving the accuracy of the force measured by the force sensor 101 located in the force sensitive region.

[0082] See also Fig.12 The housing 115 may have a first housing portion 1151, which may be flexible and bendable and completely surround the force-sensitive area of ​​the cantilever beam 116. In some embodiments, the first housing portion 1151 may be made of a flexible and bendable material (such as soft glue), or the first housing portion 1151 may be configured to have a flexible and bendable structure. When the upper arm 110 is subjected to force, the flexible and bendable first housing portion 1151 may fully release the external force and concentrate the stress of the upper arm 110 in the force-sensitive area of ​​the cantilever beam 116, thereby improving the accuracy of the force measured by the force sensor 101 in the force-sensitive area.

[0083] See also Fig.12 The upper rear portion 114 of the upper arm 110 may further include a reinforcing metal member 117. The reinforcing metal member 117 may be installed in the housing 115 and may be connected to the housing 115 (for example, by screws, etc.). The reinforcing metal member 117 may include one or more polygonal metal rings 1171 (in Fig.12 , two polygonal metal rings 1171 are shown). The inner wall of the housing 115 may have one or more two mounting portions, each of which may be used to mount a corresponding polygonal metal ring 1171. In some embodiments, the housing 115 may include one or more reinforcing metal members 17 as described above. By providing the reinforcing metal member 117 in the housing 115, the possibility of deformation of the housing 115 when the upper arm 110 is subjected to force can be reduced, thereby reducing the force component loss caused by the deformation of the housing 115, thereby improving the accuracy of the force measured by the force sensor 101 on the upper arm 110. In addition, the design of the polygonal metal ring 1171 can stabilize the positioning of the reinforcing metal member 117 in the housing 115. When the upper arm 110 is subjected to force, the polygonal metal ring 1171 can prevent the reinforcing metal member 117 from sliding relative to the housing 115, thereby further reducing the possibility of deformation of the housing 115.

[0084] In the above reference Fig.12In the described embodiment, the housing 115, the cantilever beam 116 and the reinforcing metal member 117 are disposed at the upper rear portion 114 of the upper arm 110. In other embodiments, the housing 115, the cantilever beam 116 and the reinforcing metal member 117 may also be disposed at the lower rear portion 124 of the lower arm 120.

[0085] Fig.13 A method 1300 for performing an osteotomy amount analysis according to an embodiment of the present invention is shown. In some embodiments, the method 1300 may be performed using the joint distraction system 100 described above.

[0086] At step 1301, a joint distraction device is installed at a measurement position. In some embodiments, the processing module 20 and the display module 30 of the joint distraction system 100 may be located in an external device (e.g., a host computer), and one or more joint distraction devices (e.g., joint distraction devices 10, 50, or 60) may be paired and connected with the external device. In this case, before the operator (e.g., a doctor) installs the joint distraction device at the measurement position, he may first pair and connect the joint distraction device to be used with the external device, and then the operator may input the patient information and calibrate the joint distraction device. In other embodiments, the processing module 20 and the display module 30 may be integrated in the joint distraction device. In this case, the operator may skip the pairing and connection process as described above, directly input the patient information and calibrate the joint distraction device. Next, the operator may select a measurement position as needed to install the joint distraction device. In some embodiments, the measurement position may be divided by different joint parts (e.g., the inner side of the left knee joint, the outer side of the left knee joint, the inner side of the right knee joint, the outer side of the right knee joint, etc.) and different joint flexion angles (e.g., approximately 0°, 30°, 60°, 90°, 120°, etc.). That is, the measurement position may include the inner side of the left knee joint flexed at approximately 0°, the outer side of the left knee joint flexed at 30°, the inner side of the right knee joint flexed at 60°, the outer side of the right knee joint flexed at 90°, etc. Taking the measurement position of "the inner side of the left knee joint flexed at approximately 0°" as an example, the operator may fix the patient's left knee joint to approximately 0° of flexion at step 1301. Then, the operator may install a joint distraction device (e.g., the joint distraction device 10, 50, or 60) at the measurement position. During the installation of the joint distraction device 10, 50, or 60, the joint distraction device 10, 50, or 60 may be placed in a closed state. When installed, the upper front end 111 of the upper arm 110 and the lower front end 121 of the lower arm 120 of the joint distraction device 10 , 50 or 60 may be inserted into the gap of the corresponding joint part (eg, the inner side of the left knee joint) of the patient.

[0087] Next, method 1300 may proceed to step 1303 .

[0088] At step 1303, force data and position data are obtained. In some embodiments, after the joint distraction device 10, 50 or 60 is installed at the measurement position (for example, the inner side of the left knee joint with about 0° flexion), the operator can apply force to the upper arm 110 and the lower arm 120 of the joint distraction device 10, 50 or 60, so that the upper arm 110 and the lower arm 120 are distracted and rotated relative to each other around the rotating shaft assembly 130, so that the upper front end 111 of the upper arm 110 and the lower front end 121 of the lower arm 120 are separated from each other and the tibial plateau and femoral condyle of the patient's knee joint are distracted. Under the tension of the surrounding soft tissue, the tibial plateau and the femoral condyle of the knee joint will generate a squeezing force on the upper arm 110 and the lower arm 120 of the joint distraction device 10, 50 or 60. The force sensor 101 located on the joint distraction device 10, 50 or 60 can measure the force applied to the upper arm 110 or the lower arm 120. At the same time, the position sensor 103 located on the joint distraction device 10, 50 or 60 can measure position data to determine the distance by which the tibial plateau and the femoral condyle of the knee joint are distracted. During the process of distracting the tibial plateau and the femoral condyle of the knee joint, the force sensor 101 can perform real-time measurement to obtain one or more force data that change over time. Similarly, during the process of distracting the tibial plateau and the femoral condyle of the knee joint, the position sensor 103 can also perform real-time measurement to obtain one or more position data that change over time. Each of the one or more position data obtained can correspond to (for example, correspond in time to) a corresponding force data in one or more force data.

[0089] Next, method 1300 may proceed to step 1305 .

[0090] At step 1305, a distraction pressure and a corresponding distraction distance are determined. In some embodiments, the joint distraction device 10, 50, or 60 may be communicatively coupled to the processing module 20, and may transmit the acquired one or more force data and one or more position data to the processing module 20. The processing module 20 may determine one or more distraction pressures based on the received one or more force data, and determine one or more distraction distances based on the received one or more position data. Each of the determined one or more distraction pressures may correspond to (e.g., correspond in time to) a corresponding distraction distance in the one or more distraction distances.

[0091] In some embodiments, when the operator applies force to the joint distraction device 10, 50 or 60 to distract the joint, the operator can gradually distract the joint to the target distraction distance or target distraction pressure in the manner of "apply force-withdraw force-further apply force-withdraw force again-..." In this process, due to the presence of the one-way locking mechanism 140, 150 or 160 of the joint distraction device 10, 50 or 60, even if the operator withdraws force, the joint distraction device 10, 50 or 60 can be maintained in the distracted state, and the force data obtained by the force sensor 101 at this time can more accurately reflect the tension of the soft tissue around the distracted joint. The processing module 20 can be configured to determine one or more distraction pressures by selecting the force data obtained when the operator withdraws force from one or more force data. Compared with the force data obtained when the operator applies force, the force data obtained when the operator withdraws force can show a small change or even no change over time.

[0092] In some embodiments, the position sensor 103 may include an angle encoder, which may be located at the shaft assembly 130 and may be configured to measure the rotation angle α of the upper arm 110 relative to the lower arm 120. The processing module 20 may determine the distance by which the joint is distracted (i.e., the distraction distance H) based on the rotation angle α. For example, the distraction distance H may be determined by the following formula: H = 2×L×sin(α / 2), where α is the rotation angle of the upper arm 110 of the joint distraction device 10 relative to the lower arm 120, and L is the distance from the lowest point of the upper arm 110 or the lower arm 120 to the center of the shaft of the shaft assembly 120.

[0093] Next, method 1300 may proceed to step 1307 .

[0094] At step 1307, the distraction pressure and the corresponding distraction distance are displayed. In some embodiments, the processing module 20 may be communicatively coupled with the display module 30 and transmit the determined one or more distraction pressures and one or more distraction distances to the display module 30. The display module 30 may display the one or more distraction pressures and one or more distraction distances. In some embodiments, the display module 30 may display each of the one or more distraction pressures in association with the corresponding distraction distance in the one or more distraction distances. For example, the display module 30 may display a scatter plot, a bar graph, or a curve graph with the distraction distance as the horizontal axis and the distraction pressure as the vertical axis. For another example, the display module 30 may display a table, the first column of which may include time, the second column may include the distraction distance at each time, and the third column may include the distraction pressure at each time. The table may also include one or more additional columns, such as a column displaying left and right leg information, a column displaying medial and lateral joint information, a column displaying different joint flexion angles, etc. In some embodiments, the joint distraction device 10, 50, or 60 may transmit the acquired force data and position data to the processing module 20 in real time. The processing module 20 can determine the distraction pressure and distraction distance based on the received force data and position data and transmit the determined distraction pressure and distraction distance to the display module 30 in real time. The display module 30 can display the received distraction pressure and distraction distance in real time. In this way, the operator can view the distraction pressure and distraction distance in real time during the operation of the joint distraction device 10, 50 or 60 to distract the patient's joint. This can allow the operator to flexibly adjust the force applied to the joint distraction device 10, 50 or 60 during the distraction process, so as to determine the distraction pressure at the desired distraction distance or the distraction distance at the desired distraction pressure.

[0095] Next, method 1300 may proceed to step 1309 .

[0096] At step 1309, it is determined whether there are other measurement positions to be measured. In some embodiments, after performing the above steps 1301-1307 at a measurement position (e.g., the inner side of the left knee joint at about 0° flexion), the operator can determine whether it is necessary to perform the above steps 1301-1307 at other measurement positions according to their needs, so as to obtain one or more distraction pressures and one or more distraction distances at other measurement positions. If it is determined that there are other measurement positions to be measured, the method 1300 can return to step 1301. At step 1301, a joint distraction device can be installed at the other measurement position according to the specific situation. In some embodiments, the other measurement position can be the outer side of the left knee joint at 30° flexion, and the operator can fix the corresponding joint of the patient (e.g., the left knee joint) to the corresponding flexion angle (e.g., flexion of about 30°). Then, the operator can install the joint distraction device 10, 50 or 60 at the other measurement position. If it is determined that there are no further measurement locations to be measured, method 1300 may proceed to step 1311 .

[0097] At step 1311, an osteotomy analysis is performed. In some embodiments, after obtaining the distraction pressure and the corresponding distraction distance for each of the one or more measurement positions, the processor 20 may perform an osteotomy analysis to determine the amount of osteotomy (e.g., the amount of osteotomy of the tibia and / or femur). The osteotomy analysis may include: determining a predetermined distraction pressure range [F1, F2] based on the distraction pressure and the corresponding distraction distance obtained for each measurement position; N ] and their corresponding expansion distances, where N is greater than 2. The predetermined expansion pressure range [F1, F N F1 and F in N Can be determined based on clinical experience. For example, F1 and F N It can be set by the clinician. In some embodiments, F1 can be 10N, 20N, 30N or other distraction pressure values. N It can be 120N, 130N, 140N or other opening pressure values. The multiple corresponding opening distances determined can be within the opening distance range [H1, H N ]. In some embodiments, the opening distance range [H1, H N The distraction distance step l of the adjacent distraction distances in ] can be 0.1, 0.2, 0.3, 0.5 mm or other step lengths. The bone resection analysis performed by the processor 20 may also include: based on the predetermined distraction pressure range [F1, F N] and their corresponding distraction distances, draw a curve graph of the change of distraction pressure relative to distraction distance; determine the target distraction distance based on the slope of the curve of the drawn curve graph; and determine the amount of osteotomy based on the target distraction distance. In some embodiments, the target distraction distance can be the distraction distance corresponding to the characteristic point in the drawn curve graph (for example, the point with the steepest slope, the point with the slowest slope, the point with the fastest slope change, etc.). Fig.14 FIG. 4 is a graph showing the change in the expansion pressure relative to the expansion distance according to some embodiments of the present disclosure. Fig.14 As shown, the horizontal axis of the curve graph describes the expansion height (i.e., expansion distance), and the vertical axis describes the expansion force (i.e., expansion pressure). The target expansion distance can be determined as the expansion distance corresponding to the point with the steepest slope in the curve graph, i.e., 8.00 mm. Next, method 1300 can proceed to step 1313.

[0098] At step 1313 , the analysis result is displayed. In some embodiments, the display module 30 may display the determined osteotomy amount as the analysis result for the clinician to refer to in order to determine the final osteotomy amount. Next, the method 1300 may proceed to step 1315 .

[0099] At step 1315, the method 1300 for performing osteotomy amount analysis ends.

[0100] In some embodiments, after the amount of osteotomy of the tibia and / or femur is completed based on the amount of osteotomy determined, for example, by the above-mentioned method 1300, a knee prosthesis may be installed at the patient's knee joint. Subsequently, method 1300 may be performed again for the patient with the knee prosthesis installed to obtain the distraction pressure and its corresponding distraction distance, and the osteotomy analysis may be performed again based on the obtained distraction pressure and its corresponding distraction distance to determine whether the amount of osteotomy needs to be corrected (for example, the amount of osteotomy is increased). By determining the amount of osteotomy by considering the relationship between the joint gap and the tension of the soft tissue, the precision and accuracy of knee replacement can be improved, the possibility of permanent damage to the soft tissue can be reduced, and the dependence on the doctor's experience can be reduced. In addition, a database can be established using the determined distraction pressure and its corresponding distraction distance, and a surgical model can be established before or during surgery using the database and based on real-time data, so as to provide doctors with relevant surgical reference opinions, thereby improving the success rate of the surgery.

[0101] The above steps are exemplary and are not intended to be limiting. Those skilled in the art may add one or more steps, delete one or more of the above steps, combine or replace one or more of the above steps, or adjust the order of one or more of the above steps according to their needs.

[0102] One or more modules in each embodiment of the present disclosure may be implemented by hardware. For example, it may be implemented by using at least one of application specific integrated circuits (ASICs), digital signal processors (DSPs), digital signal processing devices (DSPDs), programmable logic devices (PLDs), field programmable gate arrays (FPGAs), processors, controllers, micro-controllers, micro-processors, and electrical units for performing other functions.

[0103] Certain portions of the various embodiments of the present disclosure may be provided as a computer program product, which may include a computer-readable medium having computer program instructions stored thereon, which may be used to program a computer (or other electronic device) to be executed by one or more processors to perform processes according to certain embodiments. Computer-readable media may include, but are not limited to, magnetic disks, optical disks, read-only memories (ROMs), random access memories (RAMs), erasable programmable read-only memories (EPROMs), electrically erasable programmable read-only memories (EEPROMs), magnetic or optical cards, flash memory, or other types of computer-readable media suitable for storing electronic instructions. In addition, the embodiments may also be downloaded as a computer program product, wherein the program may be transferred from a remote computer to a requesting computer. In some embodiments, a non-transitory computer-readable storage medium has data stored thereon representing a sequence of instructions, which, when executed by a processor, causes the processor to perform certain operations, such as the above in combination with Fig.13 One or more steps in method 1300 described.

[0104] Although the present invention has been described according to the preferred embodiments of the present disclosure, it is not intended to be limited thereto, but only limited by the scope set forth in the appended claims. It should be understood by those skilled in the art that various modifications and changes may be made to the embodiments described herein without departing from the broader spirit and scope of the present invention as set forth in the appended claims.

Claims

1. A joint distraction device, characterized in that: The joint distraction device comprises: Axis assembly; an upper arm and a lower arm, the upper arm and the lower arm being rotatably connected to the rotating shaft assembly and capable of performing an open rotation and a closed rotation around the rotating shaft assembly, wherein the open rotation causes the upper front end of the upper arm and the lower front end of the lower arm to move away from each other, and the closed rotation causes the upper front end of the upper arm and the lower front end of the lower arm to move closer to each other; and A one-way locking mechanism, wherein the one-way locking mechanism has a one-way locking state and a free state, Wherein, when in the one-way locking state, the one-way locking mechanism allows the upper arm and the lower arm to rotate in an open manner and prevents the upper arm and the lower arm from rotating in a closed manner; when in the free state, the one-way locking mechanism allows the upper arm and the lower arm to rotate in an open manner and in a closed manner. The rotating shaft assembly comprises: a rotating shaft connected to the upper arm and having a reduced diameter region; and a shaft sleeve connected to the lower arm and used for sleeve-engaging the rotating shaft, The one-way locking mechanism comprises: A locking member, the locking member comprising an extrusion member, the extrusion member being disposed in a cavity of the lower arm for abutting against a diameter-changing region of the rotating shaft; and a locking fitting, wherein the locking fitting comprises the diameter-changing region of the rotating shaft, When the one-way locking mechanism is in the one-way locking state, the extrusion member abuts against the diameter-changing region of the rotating shaft, and when the one-way locking mechanism is in the free state, the extrusion member is separated from the diameter-changing region of the rotating shaft.

2. The joint distraction device according to claim 1, characterized in that: The joint distraction device further includes one or more force sensors, each of which is located at the upper arm or the lower arm to measure the force applied to the upper arm or the lower arm.

3. The joint distraction device according to claim 2, characterized in that: The upper arm has an upper front portion and an upper rear portion separated by the rotating shaft assembly, and the lower arm has a lower front portion and a lower rear portion separated by the rotating shaft assembly. The upper front portion of the upper arm has the upper front end, and the lower front portion of the lower arm has the lower front end, and the upper front end and the lower front end are configured to be suitable for insertion into a patient's joint. The upper rear portion of the upper arm and the lower rear portion of the lower arm respectively have an upper operating portion and a lower operating portion for applying a force thereon to cause the upper arm and the lower arm to spread and rotate, and Each of the one or more force sensors is located at an upper rear portion of the upper arm or a lower rear portion of the lower arm.

4. The joint distraction device according to claim 3, characterized in that: The upper rear portion of the upper arm has a cantilever beam, and the cantilever beam is configured to have a force sensitive area. At least one of the one or more force sensors is located within a force sensitive region of the cantilever beam of the upper arm.

5. The joint distraction device according to claim 4, characterized in that: The upper arm has a housing including a first housing portion which is flexible and bendable and completely surrounds the force-sensitive area for positioning at least one force sensor.

6. The joint distraction device according to claim 5, characterized in that: The upper arm has a reinforcing metal piece, and the reinforcing metal piece is used to be installed in the housing.

7. The joint distraction device according to claim 2, characterized in that: The one-way locking mechanism also includes: a push rod disposed within the cavity of the lower arm; and A button, a part of which is disposed in the cavity of the lower arm, and the button is used to be operated to push the push rod to move toward the extrusion member, thereby causing the extrusion member to abut against the diameter-changing region of the rotating shaft.

8. The joint distraction device according to any one of claims 2 to 7, characterized in that: The joint distraction device further includes a position sensor configured to measure position data, and the position data is used to determine a distraction distance of the joint distraction device.

9. The joint distraction device according to claim 8, characterized in that: The position sensor includes an angle encoder located at the shaft assembly and configured to measure a rotation angle.

10. A joint distraction system, characterized in that: The joint distraction system comprises: The joint distraction device according to claim 8 or 9; a processing module communicatively coupled to the joint distraction device and configured to: receiving one or more force data from a force sensor and one or more position data from a position sensor from the joint distraction device; determining one or more distraction pressures based on the one or more force data; and Based on the one or more position data, determining one or more distraction distances; and A display module is communicatively coupled to the processing module and is configured to display the determined one or more distraction pressures and one or more distraction distances.

11. The joint distraction system according to claim 10, characterized in that: The display module is further configured to display each distraction data of the one or more distraction distances in association with a corresponding distraction pressure of the one or more distraction pressures.

12. The joint distraction system according to claim 11, wherein: for each of the one or more measurement locations, obtaining the one or more position data, and For each of the one or more measurement locations, the one or more force data are acquired.

13. The joint distraction system according to claim 12, wherein: The processing module is further configured to: perform bone resection amount analysis based on the distraction pressure determined for each of the one or more measurement positions and the corresponding distraction distance to determine the bone resection amount, The display module is configured to display the determined bone resection amount.

14. The joint distraction system according to claim 13, wherein: The bone resection analysis includes: Based on the expansion pressure and the corresponding expansion distance obtained for each measurement position, determining a plurality of expansion pressures and the corresponding expansion distances within a predetermined expansion pressure range; Based on a plurality of expansion pressures within a predetermined expansion pressure range and their corresponding expansion distances, a curve graph showing the expansion pressure changes relative to the expansion distance is drawn; Determining a target propping distance based on a slope of the drawn curve graph, wherein the target propping distance is a propping distance corresponding to a characteristic point in the curve graph; and The amount of osteotomy was determined based on the target distraction distance.

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